OBJECTIVES: I. Determine whether combined intercostal muscle and diaphragm pacing can maintain full-time ventilatory support in patients with ventilatory dependent quadriplegia who are not candidates for phrenic nerve pacing alone. II. Evaluate the efficacy of the Medlink device to produce synchronous intercostal and diagram activation in these patients.

Condition	Treatment or Intervention
Quadriplegia	Device: Medlink spinal cord electrode

Further Study Details: 

Expected Total Enrollment:  5

PROTOCOL OUTLINE: Patients have a Medlink spinal cord electrode surgically implanted and attached to a radiofrequency receiver implanted subcutaneously over the anterior chest wall. If substantial inspired volumes can be generated by intercostal pacing, a phrenic nerve cuff electrode and radiofrequency receiver are implanted, and patients undergo combined intercostal muscle and diaphragm pacing.

Ages Eligible for Study:  18 Years   -   49 Years,  Genders Eligible for Study:  Both

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Ventilator dependent quadriplegics who are not candidates for phrenic nerve pacing alone

Must have bilateral partial or unilateral phrenic nerve function

Must have been on ventilator support for at least 6 months and unweanable

--Patient Characteristics--

Cardiovascular: No active cardiovascular disease

Pulmonary: No active lung disease

Other: No active brain disease Stable condition

Study chairs or principal investigators

Anthony F. DiMarco,  Study Chair,  Case Western Reserve University   

Study ID Numbers:  199/13307; CWRU-09169-M-91; CWRU-FDR000403
Record last reviewed:  September 2002
Last Updated:  October 13, 2004
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004415
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08